Table 2.
Outcome values
| Dichotomous outcomes |
||||||
|---|---|---|---|---|---|---|
| Lifestyle/medical management |
RYGB |
Treatment difference at 36 months |
||||
| 12 months | 36 months | 12 months | 36 months | OR (95% CI) | P | |
| Meets triple end point | 11 (19) | 5 (9) | 28 (47) | 17 (28) | 4.0 (1.3, 12.1) | 0.01 |
| HbA1c <7.0% | 19 (31) | 13 (22) | 44 (73) | 35 (58) | 4.9 (2.0, 11.7) | 0.0004 |
| LDL cholesterol <100 mg/dL | 41 (70) | 33 (55) | 47 (78) | 42 (69) | 1.8 (0.8, 3.9) | 0.14 |
| SBP <130 mmHg | 45 (76) | 30 (50) | 49 (81) | 43 (72) | 2.5 (1.1, 5.6) | 0.02 |
| HbA1c <6.0% | 5 (9) | 4 (7) | 25 (42) | 16 (27) | 5.1 (1.2, 21.5) | 0.03 |
| Full remission* | n/a | 0 (0) | n/a | 10 (17) | n/a | 0.001 |
| Full or partial remission** | n/a | 0 (0) | n/a | 22 (36) | n/a | <0.0001 |
| SBP <140 mmHg | 53 (90) | 43 (73) | 55 (92) | 55 (91) | 4.3 (1.3, 14.4) | 0.02 |
| Use of prescription medication | ||||||
| Insulin | 26 (44) | 28 (47) | 12 (20) | 10 (16) | 0.19 (0.07, 0.48) | 0.0005 |
| Other glycemic medicines | 57 (96) | 47 (80) | 21 (35) | 25 (42) | 0.16 (0.06, 0.41) | 0.0002 |
| LDL medicines | 38 (65) | 32 (54) | 23 (38) | 22 (37) | 0.50 (0.23, 1.07) | 0.07 |
| Blood pressure medications | 42 (72) | 34 (57) | 23 (39) | 24 (39) | 0.44 (0.19, 1.02) | 0.055 |
| At goal without medication | ||||||
| Triple end point | 0 (0) | 1 (2) | 13 (22) | 8 (14) | 9.1 (1.1, 75.0) | 0.04 |
| HbA1c <7.0% | 0 (0) | 3 (5) | 34 (58) | 30 (52) | 22 (4.6, 105) | 0.0001 |
| LDL cholesterol <100 mg/dL | 15 (26) | 15 (26) | 31 (52) | 24 (41) | 1.9 (0.9, 4.2) | 0.11 |
| SBP <130 mmHg | 15 (25) | 15 (25) | 32 (54) | 28 (52) | 3.1 (1.3, 7.6) | 0.01 |
| Continuous outcomes |
||||||
|---|---|---|---|---|---|---|
| Lifestyle/medical management |
RYGB |
Treatment difference at 36 months |
||||
| 12 months | 36 months | 12 months | 36 months | Estimate (95% CI) | P | |
| HbA1c (%) | 7.8 (2.3) | 8.6 (3.5) | 6.4 (1.6) | 6.7 (2.0) | −1.9 (−2.6, −1.2) | <0.0001 |
| Serum lipids | ||||||
| LDL cholesterol (mg/dL) | 88 (50) | 103 (70) | 83 (40) | 90 (46) | −13.3 (−27.7, 1.0) | 0.07 |
| HDL cholesterol (mg/dL) | 42 (16) | 46 (18) | 51 (20) | 53 (19) | 7.0 (2.5, 11.6) | 0.003 |
| Blood pressure | ||||||
| SBP (mmHg) | 124 (17) | 130 (28) | 117 (22) | 123 (24) | −7.6 (−13.7, −1.5) | 0.01 |
| DBP (mmHg) | 74 (13) | 77 (19) | 68 (14) | 71 (17) | −6.5 (−10.8, −2.3) | 0.003 |
| Weight (kg) | 90.6 (24.3) | 92.1 (29.2) | 73.5 (19.8) | 77.9 (20.9) | −14.3 (−20.1, −8.5) | <0.0001 |
| Percent weight change (%) | −7.3 (12.5) | −6.3 (16.1) | −25.5 (13.5) | −21.0 (14.5) | 14.8 (11.0, 18.7) | <0.0001 |
| BMI (kg/m2) | 31.7 (5.5) | 32.1 (6.8) | 26.0 (5.3) | 27.7 (5.8) | −4.5 (−6.0, −3.0) | <0.0001 |
| Medications prescribed | ||||||
| For glycemia | 2.6 (1.0) | 2.1 (1.3) | 0.8 (1.0) | 0.7 (1.0) | −1.4 (−1.4, −1.3) | <0.0001 |
| For dyslipidemia and blood pressure | 2.4 (1.8) | 1.8 (1.4) | 1.1 (1.1) | 1.1 (1.1) | −0.7 (−1.1, −0.3) | 0.001 |
| Total | 4.9 (3.1) | 3.8 (3.3) | 1.8 (2.7) | 1.8 (2.4) | −2.0 (−2.7, −1.4) | <0.0001 |
Dichotomous outcomes are N (%) with characteristic and OR (95% CI). Continuous outcomes are mean (SD) and estimated difference (95% CI). All values estimated using multiple imputations for missing data. Treatment comparisons adjusted for sites. Boldface type indicates the primary end point. n/a, not applicable; RYGB, Roux-en-Y gastric bypass.
*Full remission: defined as HbA1c <6.0% for a full year (i.e., visits 24 and 36) and no glycemic medications during that time. P value for treatment difference determined by using Fisher exact test.
**Full or partial remission: same as full remission, but replace 6.0% with 6.5%.